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Recruiting NCT06691087

Sound Perception Study of Hearing-impaired People With Hearing Aids

No phase Interventional Auditory Perception

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Influence of the parameters of the sound timbre on the perception of a sound, Complex sound scene comprehension test, Complex sound scene comprehension test with hearing aids.
Who it may be relevant to
Registry conditions: Auditory Perception. Basic parameters: 60 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

ÉTude de la pERception soNorE de Personnes maLentendantes équipées d'Aides Auditives

Overview

The aim of the ETERNEL project will be to study the influence of the perception of a single sound timbre on the understanding of a complex sound scene in hearing-impaired people with hearing aids. This will be done by quantifying the inability to manage a complex sound scene as a function of the timbre of the sounds making it up. The more a sound interferes with understanding the complex sound scene, the more salient that sound is considered to be. In this way, the investigators can determine which timbre dimensions make sounds particularly salient for the hearing impaired.

Interventions

  • Behavioral Influence of the parameters of the sound timbre on the perception of a sound
    The experiment consists of evaluating the sound level of n complex stimuli, then equalising them in loudness, in order to measure a loudness curve in function of timbre descriptors. The stimuli will then be listened to again in pairs. The task is there to compare the stimuli using a VAS to indicate how different the two sounds are.
  • Behavioral Complex sound scene comprehension test
    The experiment consists in identifying the parameters of the sound timbre that most disturb the understanding of complex sound scenes, by asking the participants to identify sounds whose timbre has been modified.
  • Behavioral Complex sound scene comprehension test with hearing aids
    The experiment will be identical to intervention 2. This time, the modification of the stimulus timbres will focus on the most problematic dimensional modifications, i.e. those where the difference between normal-hearing and hearing-impaired listeners is greatest. We will then modify the signal processing parameters of the hearing aid simulator (for example, the size of the averaging window or the gain balance of the filters), to observe their impact on the salience of certain stimuli.

Primary outcome measures

  • Percentage of correct answers in melody comparison tasks in the hearing-impaired group compared with the normal-hearing group, [Time frame: 3-hours]
Secondary outcome measures (3)
  • Characterisation of the dissimilarity between pairs of stimuli measured by a continuous perceptual scale [Time frame: 3-hours]
  • Evaluation of the perceived loudness level of a set of stimuli, measured using scales of magnitude. [Time frame: 3-hours]
  • Comparison between the results of speech audiometry in noise, i.e number of words correctly repeated, with native settings versus settings minimising the discomfort of salient sounds for each participant with hearing loss. [Time frame: up to 24 months]

Eligibility criteria

Inclusion criteria

For all participants:

  • Age between 60 and 75
  • Native French speaker
  • Have given their consent to take part in the study.
  • Declare that they have an active social life or hobbies that stimulate their cognitive abilities
  • Have a MOCA score above 26
  • No tympano-ossicular dysfunction.
  • Voice in noise audiometry results showing normal results.

For participants with impaired hearing :

  • Pure tone audiometry showing audiograms of type N3 or N4 and symmetrical between the two ears.
  • Report having experienced problems with abnormally prominent sound.

For participants with normal hearing:

\- Pure tone audiometry showing audiograms with losses of less than 30 dBHl.

Exclusion criteria

  • Be under guardianship or curatorship,
  • Be deprived of liberty by judicial or administrative decision, or be under legal protection.
  • Bear the consequences of an ear infection and/or have a history of an ENT disease that permanently affects hearing or balance (vestibular schwannoma, Ménière's disease, sudden or fluctuating deafness, congenital hypoacusis).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • CeRIAH — Paris

Identifiers

NCT: NCT06691087 · 2024-040 · 2024-A01112-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗